Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05956002 | A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants | PHASE1 | COMPLETED | 16 | — | — | Sep 4, 2023 | Jan 4, 2024 | Feb 10, 2025 | 1 | Belgium |
AUClast was calculated using linear/log trapezoidal method.
AUCinf was calculated as AUClast + (Clast\*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference) followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2) followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3) followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) |
| Sequence 2 | EXPERIMENTAL | Single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3) followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference) followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2) followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) |
| Sequence 3 | EXPERIMENTAL | Single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2). Followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference).followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) Followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) |
| Sequence 4 | EXPERIMENTAL | Single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1). Followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) |
| Name | Type | Description |
|---|---|---|
| Estraimod Immediate Release (IR) | DRUG | an immediate release tablet |
| Etrasimod Mini Tab in water | DRUG | very small tablet mixed in water |
| Etrasimod Mini Tab in chocolate pudding | DRUG | very small tablet mixed in chocolate pudding |
| Etrasimod Mini Tab in yogurt | DRUG | Very small tablet mixed in yogurt |
| Etrasimod Mini Tab in applesauce | DRUG | Very small tablet mixed in applesauce |
Inclusion Criteria: * Healthy participants * BMI 16 to 32 kg/m2 * body weight more than 50kg Exclusion Criteria: * Ongoing or past history of significant medical conditions * Eye disorders such as macular edema or uveitis * Ongoing or recent infections * Use of prescription or non prescription me...